Sanofi Corporate Integrity Agreement 2015
Sanofi recently signed their latest Corporate Integrity Agreement (CIA) to settle the latest round of charges of…
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Life Science Compliance Update December 2015 Issue: Back to the Future
The December 2015 issue of Life Science Compliance Update, available with a subscription here, offers a more in-depth…
Senators McCain and Grassley Request HHS for Approval of Importation of…
As the controversy over drug pricing continues to heat up, Senators Chuck Grassley and John McCain have started to place…
FDA Agency Update December 2015
As 2015 comes to a close for the FDA, it remains an agency in transition. The agency should soon see a new commissioner…
Senate Finance Committee Releases Results of Investigation Into Gilead’s…
Senate Finance Committee Ranking Minority Member Ron Wyden and Republican member Charles Grassley released the results…
Study Explores Lack of Sunshine Act Guidance From Professional Medical…
As with any large piece of legislation, the Sunshine Act (Open Payments) has conjured up a wide variety of reactions, including…
Novartis Settlement and Corporate Integrity Agreement Amendment
We have previously written about the proposed Novartis AG settlement relating its False Claims Act suit. The suit…
Pharmaceutical Pricing – A Reminder of the Value Equation
We previously wrote about the actions Congress is taking to "combat rising prescription drug prices," and the rhetoric…
Stage III Meaningful Use CMS Doubles Down as Opposition Mounts
Despite Congressional interest in delaying Stage 3 of the electronic health record Meaningful Use program and the AMA…
House E&C Committee Turns Focus to the Regulation of Diagnostic Tests…
Background
The House Energy & Commerce Committee's Health Subcommittee held a hearing on November 17, 2015, to discuss a…